Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies

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The study will be conducted in three parts. Part 1 is a dose escalation phase to determine the maximum tolerated dose (MTD) of INCB040093, a PI3Kδ inhibitor, or a tolerated, pharmacologically active dose; Part 2 will evaluate the combination of INCB040093 and itacitinib (INCB039110), a JAK1 inhibitor, to determine the MTD of the combination or a tolerated dose that produces substantial pharmacologic inhibition of both targets; Part 3 will further evaluate the chosen doses of INCB040093 alone and in combination with itacitinib (INCB039110) in subjects with relapsed/refractory B-cell malignancies.

Safety and tolerability of INCB040093 as monotherapy and when given in combination with itacitinib as determined by clinical laboratory assessments, physical exams, 12-lead ECG and summary of adverse events [ Time Frame: Measured every 3 weeks until progression. ]

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

• Aged 18 years or older, with lymphoid malignancies of B-cell origin as follows:

The subject must not be a candidate for potentially curative therapy, including stem cell transplant.

Exclusion Criteria:

Received an investigational study drug within 28 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug.

Received any approved anticancer medications within 21 days or 5 half-lives (whichever is longer) prior to receiving their first dose of study drug (42 days for nitrosoureas) EXCEPT steroids at ≤ 10 mg prednisone daily (or equivalent).

Has history of brain metastases or spinal cord compression, or lymphoma involving the central nervous system.

Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 3.

Received allogeneic hematopoietic stem cell transplant within the last 6 months, or has active graft versus host disease (GVHD) following allogeneic transplant, or is currently receiving immunosuppressive therapy following allogeneic transplant.

Received autologous hematopoietic stem cell transplant within the last 3 months.

Laboratory parameters not within the protocol-defined range.

Current or recent history (<30 days prior to screening and/or <45 days prior to dosing) of a clinically meaningful bacterial, fungal, parasitic or mycobacterial infection.

Current clinically active viral infection.

Known history of infection with the human immunodeficiency virus (HIV).